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Consumers, Health And Food Executive Agency Functions of EU-RL, NRL and Official Control Laboratories Accreditation and quality requirements Functions of EU-RL and NRL. Requirements for Accreditation request Types of Accreditation: fixed and flexible 2

Consumers, Health And Food Executive Agency Background 3 Competent Authorities’ mission is finalized to guarantee food safety by the right implementation of the existing food and feed legislative provisions. Measurements are the key tool for assessing this mission, monitoring not only products that are purchased within national borders, but also performing import/export control in harbours and at EU borders. In order to keep the costs of monitoring affordable, duplication and multiplication of analytical work should be avoided. The need of a Reference Organisation deputed to harmonise the principles, diagnostic tools, operating procedures, is a MUST for targeting the CAs’ mission. A parallel result is the facilitation of trade issues, contributing at the resolution of disputes when disagreements occur.

Consumers, Health And Food Executive Agency EU-RLs’ mission 4 The designation of European Union must contribute to a high quality and uniformity of analytical results. This objective can be achieved by activities such as the application of validated analytical methods, ensuring that reference materials are available, the organization of comparative testing and the training of staff from laboratories. The activities of reference laboratories cover all the areas of feed and food law and animal health, in particular those areas where there is a need for precise analytical and diagnostic results.

Consumers, Health And Food Executive Agency List of Reference Laboratories 5 REGULATION (EC) No 882/2004 as amended by COMMISSION REGULATION (EC) No 776/2006 of 23 May 2006 amending Annex VII to Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards Community reference laboratories

Consumers, Health And Food Executive Agency EU-RLs Reference Laboratories Contaminants 6 Mycotoxins (JRC, Geel – Belgium) Polycyclic aromatic hydrocarbons (JRC, Geel – Belgium) Heavy metals in feed and food (JRC, Geel - Belgium) PCBs and Dioxins in feed and food (Chemisches und Veterina ̈ runtersuchungsamt (CVUA) Freiburg Postfach , D Freiburg, Germany)

Consumers, Health And Food Executive Agency Union Reference Laboratories 7 REGULATION (EC) No 882/2004, Article 32 The Union reference laboratories for feed and food referred to in Annex VII shall be responsible for: (a) providing national reference laboratories with details of analytical methods, including reference methods; (b) coordinating application by the national reference laboratories of the methods referred to in (a), in particular by organising comparative testing and by ensuring an appropriate follow-up of such comparative testing in accordance with internationally accepted protocols, when available; (c) coordinating, within their area of competence, practical arrangements needed to apply new analytical methods and informing national reference laboratories of advances in this field;

Consumers, Health And Food Executive Agency Union Reference Laboratories 8 REGULATION (EC) No 882/2004, Article 32 The Union reference laboratories for feed and food referred to in Annex VII shall be responsible for: (d) conducting initial and further training courses for the benefit of staff from national reference laboratories and of experts from developing countries; (e) providing scientific and technical assistance to the Commission, especially in cases where Member States contest the results of analyses; (f) collaborating with laboratories responsible for analysing feed and food in third countries.

Consumers, Health And Food Executive Agency National Reference Laboratories 9 REGULATION (EC) No 882/2004, Article 33 Member States shall arrange for the designation of one or more national reference laboratories for each Union reference laboratory referred to in Article 32. A Member State may designate a laboratory situated in another Member State or European Free Trade Association (EFTA) Member and a single laboratory may be the national reference laboratory for more than one Member State.

Consumers, Health And Food Executive Agency National Reference Laboratories 10 REGULATION (EC) No 882/2004, Article 33 These national reference laboratories shall: (a) collaborate with the Union reference laboratory in their area of competence (b) coordinate, for their area of competence, the activities of official laboratories responsible for the analysis of samples in accordance with Article 11 (c) where appropriate, organise comparative tests between the official national laboratories and ensure an appropriate follow-up of such comparative testing

Consumers, Health And Food Executive Agency National Reference Laboratories 11 REGULATION (EC) No 882/2004, Article 33 These national reference laboratories shall: (d) ensure the dissemination to the competent authority and official national laboratories of information that the Union reference laboratory supplies; (e) provide scientific and technical assistance to the competent authority for the implementation of coordinated control plans adopted in accordance with Article 53; (f) be responsible for carrying out other specific duties provided for in accordance with the procedure referred to in Article 62(3), without prejudice to existing additional national duties.

Consumers, Health And Food Executive Agency National Reference Laboratories 12 REGULATION (EC) No 882/2004, Article 53 Coordinated control plans The Commission may recommend coordinated plans in accordance with the procedure referred to in Article 62(2). These plans shall be: (a) organised annually in accordance with a programme; and (b) where considered necessary, organised on an ad hoc basis, in particular with a view to establishing the prevalence of hazards in feed, food or animals.

Consumers, Health And Food Executive Agency EU-RL/NRL Network 13 How does a EU-RL/NRL Network act: The EU-RL organizes at least 1 workshop every year, where news and actual problems are discussed. The EU Commission representative is also invited to inform the network about current activities of the Commission. The EU-RL organizes at least 2 proficiency tests per year, which are mandatory for NRLs and open for OFLs. All the NRLs inform the OFLs, that there will be no national PT and therefore the EU-RL PT is more or less mandatory for the OFLs. This leads to more than 100 participants in these PTs which allow a statistically reliable evaluation.

Consumers, Health And Food Executive Agency EU-RL/NRL Network 14 How does a EU-RL/NRL Network act: The EU-RL appoints working groups for special issues, where specialized NRL representatives are invited to contribute according to their knowledge. An example: For Mycotoxin analysis there exists the following: Sampling Sample preparation Identification criteria in LC-MS/MS analysis of mycotoxins Harmonization of the calculation of the measurement uncertainty.

Consumers, Health And Food Executive Agency CRL/NRL Network 15 Examples for NRL activities: Regular activities: -Participation in EU-RL workshops and PTs. -Organisation of PT - Yearly report to competent authority about activities - Carrying out the analyses of the official control samples. - At least yearly letters to inform OFLs about news from EU-RL

Consumers, Health And Food Executive Agency CRL/NRL Network 16 Examples for NRL activities: Support of authority (examples): -EC plans to lower the maximum level for e.g. baby food, authority asks NRL if the control of the lower limit is analytically possible -Contamination case at a farm: authority asks for support during on-site inspection, and for sampling and analysis.

Consumers, Health And Food Executive Agency Official Laboratories 17 REGULATION (EC) No 882/2004, Article 12 Official laboratories 1.The competent authority shall designate laboratories that may carry out the analysis of samples taken during official controls.

Consumers, Health And Food Executive Agency Official Laboratories However, competent authorities may only designate laboratories that operate and are assessed and accredited in accordance with the following European standards: (a) EN ISO/IEC on ‘General requirements for the competence of testing and calibration laboratories’; (b) EN on ‘General criteria for the assessment of testing laboratories’; (c) EN on ‘Calibration and testing laboratory accreditation system — General requirements for operation and recognition’,

Consumers, Health And Food Executive Agency Accreditation 19 What does accreditation mean? Accreditation is the formal recognition of the competence of - testing and calibration laboratories - inspection bodies - certification bodies By Accreditation Bodies Accreditation Decree / Accreditation Certificate

Consumers, Health And Food Executive Agency Accreditation 20 Benefits of Accreditation Enhancing the laboratory competence to be recognized nationally and internationally Harmonisation of standards and procedures to make results comparable Confidence and reliability in test results Transparency Mutual recognition and acceptance of testing and calibration results

Consumers, Health And Food Executive Agency Accreditation 21 Laboratory accreditation requires conformity with the international standard ISO/IEC 17025: - „General requirements for the competence of testing and calibration laboratories“ ( ) contains all the requirements that testing labs have to meet if they wish to demonstrate that : - they operate under QMS, - are technically competent - are able to generate technically valid results

Consumers, Health And Food Executive Agency Accreditation 22 Main elements of ISO 17025: - Management requirements – clause 4 (requirements of ISO 9001 incorporated) - Technical requirements – clause 5 A full and compliant documentation is a prerequesite for application for accreditation!

Consumers, Health And Food Executive Agency Accreditation process 23 Submission of Application (QM Handbook, Accreditation scope, Equipment and Document lists, Organigram, PT performances) Initial review & discussion with client Document review Preliminary site visit Selection of the inspective team Inspective visit Inspective report Accreditation Advisory Board Decision Issuing of accreditation certificate 1 Surveillance visit Periodical reassessment

Consumers, Health And Food Executive Agency FIXED SCOPE 24 Historically, accreditation has been based on so called fixed scopes of accreditation, published by the accreditation body (AB). The fixed scope does not readily enable additional or modified activities to be added to a body’s scope without further assessment, even where competence in this general area has already been demonstrated.

Consumers, Health And Food Executive Agency DEFINITION of FLEXIBLE SCOPE 25 Flexible accreditation allows the laboratory to carry out changes within its accreditation without having to apply to AB. Here are some examples: Introduction of new methods within a specific scope Implementation of changes for non-standardised methods that are already included in the accreditation decision Introduction of new properties, variables, analytes and measurement areas in a method that has already been accredited Introduction of new versions of standard methods Introduction of new products/new sample types in a method that has already been accredited.

Consumers, Health And Food Executive Agency Fixed scope vs Flexible scope 26 Fixed scopeFlexible scope Method validation (ILC: method meets the minimum performance criteria) Method implementation (WIs: method fixed) Method verification (MPRs met by the laboratory) Method accreditation (AB: criteria of ISO/IEC are met) Method validation (ILC: method meets the minimum performance criteria) Method implementation (WIs: method fixed) Method verification (MPRs met by the laboratory) Method accreditation (Lab: criteria of ISO/IEC are met, reviewed by AB at the next audit, no scope extension required, provided method falls under an existing flexible scope) ILC - interlaboratory comparison, WI – working instruction, MPR – minimum performance requirements, AB – accreditation body, ISO – International Standardization Organisation More CONTROL MoreTRUSTMoreTRUST By Stefanie Trapmann

Consumers, Health And Food Executive Agency Fixed scope vs Flexible scope 27 Analytical method Fixed Mycotoxins Fixed Matrix FIXED SCOPE Different food/feed matrices Different mycotoxin class Different extraction/cleanup procedures Different LC-techniques Different physical status/composition FLEXIBLESCOPEFLEXIBLESCOPE A solution for managing emergencies

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